As a social entrepreneur with ME Foggy Dog, I started beavering away behind the scenes on a new campaign in mid-August 2021.
I knew the NICE guideline publication was coming, I also fully anticipated a backlash and non-compliance to the recommendations. I pre-empted the publication and got to work.
I believe in transparency so am going to share with you the emails I sent, and the responses received, so you can understand where we are RIGHT NOW.
Dear Sirs,I fully understand that you are the regulatory body for medicines and medical devices. However, I am wondering if you also regulate other ‘treatments’ that are not drug-based or patented/manufactured.As you will be aware, the NICE M.E/C.F.S guidelines review has been paused and there is every chance that Graded Exercise Therapy will continue to be recommended to M.E/C.F.S patients as a ‘treatment’ and/or a ‘cure’ by medical professionals, despite NICE recommending, in their first draft in November 2020, that neither GET or CBT should be recommended to ME/CFS patients after spending over 3 years reviewing the evidence and hearing patient testimonies.In recent weeks, proponents of GET and CBT have stated that there are no reported harms from either ‘treatment’. As you are probably aware this is because patients do not have a reporting mechanism available to them.I am writing to ask if you would consider creating a reporting mechanism for anything that is heralded as a ‘treatment’ or ‘cure’ by the NHS, in this particular case GET and CBT. A mechanism in which patients to log their name, address, the date, and healthcare professional/clinic that recommended these treatments as well as the effects of these ‘treatments’ – somewhere to scan appropriate paperwork if possible.If it is not possible to remove GET as a ‘treatment or ‘cure’, I believe patients deserve somewhere to report harms.I look forward to hearing from you.Regards,Sally Callow
Response received from MHRA 6th September 2021
Thank you for your email.
Please note that these types of treatments fall outside the remit of the MHRA and therefore unfortunately we are unable to help. Our understanding is that it might be done via the HCP or organisation providing the treatment.
MHRA Customer Service Centre
Emails sent to Penny Mordaunt MP 31st August 2021
Please see the forwarded email below (MHRA email)
As you can see, I emailed the MHRA last week regarding GET and CBT being recommended for ME/CFS.
NICE has not advised caution when recommending GET/CBT as a precaution during their ‘delay’ and so I believe patients are potentially at risk. Yet, these patients will have nowhere to report harms to if they participate in this ‘treatment’. This harm is now relevant to Long Covid as many Long Covid patients are experiencing the cardinal symptom of M.E – Post Exertion Malaise (85% have this symptom/characteristic). It is too soon to know whether these patients now have M.E or whether this unique characteristic is now shared by 2 illnesses.
Could you raise this issue with the Department of Health and Social Care?
I would be very grateful for your support in this matter.
Response from Penny Mordaunt’s Communication’s Officer 9th September 2021
Thank you for contacting our office.
Rest assured, I have raised your correspondence with the Minister in charge and will get back to you once I have received a response.
** No further correspondence has been received**
Email sent to Stephen Morgan MP on 15th October 2021
Dear Mr Morgan,
As you are aware, the NICE guidelines have been delayed and an ‘unprecedented’ roundtable is being held next week.
If NICE decide not to update its guidelines and continues to recommend Graded Exercise Therapy and Cognitive Behavioural Therapy, despite seeing swathes of evidence of harm during the review which lasted well over three years, can I please ask for your support in asking for there to be a system put in place by which M.EC.F.S patients can report harms from these ‘treatments’?
Is this something you could raise in Parliament?
I have contacted the MHRA and asked if they could create a system to report harms, I am aware that the MHRA deal with devices and drug treatments. I believe that anything recommended as a ‘treatment’ by the NHS and NHS England should be regulated. That includes GET and CBT. MHRA have told me this does not/can not come under their remit.
Interestingly, proponents of GET and CBT have expressed surprise at claims of harms as there have been no officially reported harms from the patient community. This is because there is no where to report harm to. I strongly believe that, if NICE do not see sense, a new reporting system has to be implemented. Patients need to ability to officially report that GET and/or CBT has negatively impacted their health.
I would be grateful for your support in this matter.
Response received 28th October 2021
(I know……I’m an M.E advocate and founder of a training organisation….)
Thank you for contacting me about national clinical guidelines for myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS).
ME is a highly complex condition. It is vital that patients receive the best treatment and care that takes account of their needs. Despite so many people being affected by this condition, 90% of cases are thought to go undiagnosed, and people with ME are substantially undercounted and undertreated. In some cases, patients are left waiting over a year for a diagnosis, despite national guidelines stating that a diagnosis should be made within four months of the onset of symptoms.
The National Institute for Health and Care Excellence (NICE) is responsible for establishing guidelines on the diagnosis and management of ME. It recognises that existing guidelines are outdated and that patients are not receiving the full picture on recommended treatments, such as studies that have shown the inadequacy of cognitive behavioural therapy (CBT) or harms of graded exercise therapy (GET).
As you know, NICE was expected to publish its updated clinical guidelines on 18 August 2021. This followed several earlier delays to publication. In a statement issued on 17 August 2021, NICE paused publication due to “issues raised during the pre-publication period”. I understand the disappointment that will be felt by many at this decision.
I am aware from reports that NICE was expected to advise against the use of CBT and GET in people with ME. However, NICE expressed concerns that its recommendations were not widely supported by medical professionals. Its decision to pause publication is reportedly in response to concerns raised by some royal colleges, namely regarding the lack of alternative options to treat ME/CFS in the absence of CBT and GET.
ME research charities and patient advocacy groups have expressed disappointment at this last minute decision to pause publication, arguing that this will only delay required improvements to patient care.
Last week, NICE announced they were now confident that the guidelines can be effectively implemented and were due to discuss the input from the meeting also held last week with a view to publication.
People with ME/CFS have been waiting far too long for updated clinical guidelines. I urge Ministers to work with patients, charities, researchers and NICE to ensure that treatment and care is appropriate and that guidelines provide safe and practical recommendations.
At this time, I am uncertain which body any harms from treatment wold be reported to, or who would be responsible for creating this process. Therefore my team and I are looking in to this, and we will be back in touch as soon as we receive any response to our enquiries.
Thank you once again for contacting me about this issue.
I feel this reply missed the point of my email. I know there is currently nowhere to report harms to. That was the point….. No further communication has been sent or received.
Email sent to Vicky Foxcroft MP (Shadow Minister for Disabled People) 24th October (5 days before the NICE guidelines publication)
Dear Ms Foxcroft,I am contacting you in your capacity as the Shadow Minister for Disabled People.As you are aware, the NICE guidelines have been delayed and an ‘unprecedented’ roundtable was held last week. The guidelines are anticipated to be published either this week or next.The final draft version was leaked online and this version does not go far enough to prevent harm to patients as a result of medical professionals recommending increased activity or exercise to patients as ‘treatments’. We are already seeing the language being altered to not raise any red flags.Anecdotally, as a M.E/C.F.S advocate, I have seen a number of medical professionals state on social media that, irrespective of what is included within the NICE guidelines, they will continue to recommend Graded Exercise Therapy to M.E/C.F.S patients.NICE spent over 3 years reviewing swathes of evidence of harm as a result of GET and increased activity, can I please ask for your support in asking for there to be a system put in place by which M.EC.F.S patients can report harms from these ‘treatments’?Is this something you could help me with and/or raise in Parliament?I have contacted the MHRA and asked if they could create a system to report harms, I am aware that the MHRA deal with devices and drug treatments. I believe that anything recommended as a ‘treatment’ by the NHS and NHS England should be regulated. That includes GET and increased activity. MHRA have told me this does not/can not come under their remit.Interestingly, proponents of GET have expressed surprise at claims of harms as there have been no officially reported harms from the patient community. This is because there is no where to report harm to. I strongly believe that a new reporting system has to be implemented. Patients need the ability to officially report that GET has negatively impacted their health.Given that many Long Covid patients now also have the key defining characteristic of M.E – Post Exertion Malaise and are being referred for exercise ‘rehab’ programmes in leisure centres and gyms, there is a very clear need for a mechanism to report harms from exercise. Most Physiotherapists do not know how to screen for PEM, it is highly doubtful that gym instructors know how to screen for it when it is not included in any Physiology handbooks.I would be grateful for your support in this matter.Best wishes,Sally Callow
Response received from Vicky Foxcroft MP’s Office Manager on 3rd November 2021
Many thanks for your email to Vicky.
We have this evening tabled a number of questions regarding what steps will be taken to ensure that medical practitioners are no longer recommending GET following the publication of the new guidelines. We have also asked whether a reporting system will be put in place.
Once we have received responses to these questions, Vicky would be happy to follow up with a letter to the Department of Health and Social Care if you feel it would be useful.
Thanks again for getting in touch. We’ll let you know when we have received the responses.
See the three tabled questions and responses below
There are no plans to put in place a new reporting system to enable myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS) patients to report harms resulting from graded exercise therapy. The National Institute for Health and Care Excellence’s updated guideline does not recommend the use of graded exercise therapy in the management of ME/CFS and clinicians are expected to take this recommendation fully into account in the care and treatment of individual patients.
All patients have the right to make a complaint about any aspect of National Health Service care, treatment or service, and this is firmly written into the NHS Constitution. Most hospitals have a Patient Advice and Liaison Service which can be contacted if there is a problem with the treatment or care received while in hospital.
I believe this answer to be naive and blinkered, M.E patients have been reporting harms to their healthcare provider, CCG and PALS for well over a decade. These reports are not taken seriously and look where we are today.
My petition was launched on 2nd November 2021.
I/we are petitioning Savid Javid MP (Secretary of State for Health and Social Care) and Ms Amanda Pritchard (CEO of NHS England). Although this petition has been brought about by the M.E/C.F.S patients’ struggles with GET and CBT, many people, with all sorts of illnesses, are harmed by non-pharmaceutical ‘treatments’ and so this petition will benefit many different people. Obviously, because of overlaps with PEM, any new reporting mechanism will also benefit Long Covid patients.
Please sign and share this petition as much as you are able to. We need to reach a significant number of signatures for this campaign to be taken seriously. Anyone can sign it, it doesn’t matter where you are located around the world. Please also leave a short comment if you have been personally harmed by GET or CBT.
This is where my work with ME Foggy Dog and Stripy Lightbulb CIC overlap. I sent this email to MS Pritchard on 5th November 2021 as MD of Stripy Lightbulb CIC. To be clear – both ME Foggy Dog and Stripy Lightbulb CIC work for the benefit of the M.E/C.F.S patient community. Both are social enterprises. However, ME Foggy Dog is an advocacy platform and Stripy Lightbulb CIC is a Community Interest Company that offers structured CPD accredited online training to healthcare, business, and education professionals.
Dear Ms Pritchard,
This is a national issue and so I am contacting you directly.
As a M.E/C.F.S and Long Covid patient, M.E/C.F.S advocate, and social entrepreneur tackling the M.E/C.F.S social issue, I was pleased to hear this question (below) from Baroness Finlay of Llandaff in the House of Lords on the 12th October 2021.
‘Will the Government work with commissioners to ensure that appropriate specialist services for patients with ME are developed and continue, and that services monitor accounts of harms as well as benefits?’
It is becoming increasingly clear that proponents of Graded Exercise Therapy and Cognitive Behavioural Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome are going to ‘push back’ against the newly published NICE guidelines and continue to offer rebranded GET to patients with M.E/C.F.S and Long Covid.
Their ‘push back’ started a few days after the publication of the new guideline – https://www.rcplondon.ac.uk/
news/medical-leaders-sign- joint-statement-response-nice- guidance-mecfs The Royal College of General Practitioners has now also publicly commented in favour of the Lightning Process – again, NICE has stated this should not be recommended, in any form or name, to M.E/C.F.S patients.
Anecdotally, as a M.E/C.F.S advocate, I have seen a number of medical professionals and ‘CFS clinics’ state on social media that, irrespective of what was included within the NICE guidelines, they will continue to recommend Graded Exercise Therapy and Cognitive Behavioural Therapy as ‘treatments’ to M.E/C.F.S patients.
I have contacted the Medicines and Healthcare products Regulatory Authority (MHRA) and asked if they could create a system to report harms, I am aware that the MHRA deal with devices and drug treatments. I believe that anything recommended as a ‘treatment’ by the NHS and NHS England should be regulated. That includes GET and increased activity. The MHRA have told me this does not come under their remit.
Interestingly, proponents of GET have expressed surprise at claims of harms (whilst also stating in the media that they are aware that ‘some’ have been harmed) as there have been no officially reported harms from the patient community. This is because there is nowhere to report harm to. I strongly believe that a new reporting system has to be implemented. Patients need the ability to officially report that GET, or increased activity by any name, has negatively impacted their health.
Given that many Long Covid patients now also have the key defining characteristic of M.E – Post Exertion Malaise and are being referred by GPs for exercise ‘rehab’ programmes in leisure centres and gyms, there is a very clear need for a mechanism to report harms from exercise. Most Physiotherapists do not know how to screen for PEM, it is highly doubtful that gym instructors know how to screen for it when it is not included in any Physiology handbooks. As the founder of Stripy Lightbulb CIC, an online training company that trains professionals (healthcare, business, and education) about the poorly understood disease, I was surprised and shocked by this development. To offer these exercise ‘rehab’ programmes, instructors have to complete commercial training in order to be qualified to ‘rehabilitate’ post-viral, chronically sick patients. Unfortunately, according to the instructors I have spoken to, the training does not include Post-Exertional Malaise. This past week, I have been told by M.E/C.F.S patients that they too have been referred to these exercise ‘rehab’ programmes by their GP.
I am currently petitioning the NHS to create a new mechanism by which M.E/C.F.S (and Long Covid) patients will be able to report harms. See the petition here – https://www.change.org/p/
department-of-health-and- social-care-we-demand-the- creation-of-a-new-mechanism- by-which-m-e-c-f-s-patients- can-report-harms-ab215021- 5d66-4f72-9ba2-06a633f298f3? recruiter=1232176643& recruited_by_id=72f07290-3bb6- 11ec-9085-116766684916&utm_ source=share_petition&utm_ medium=copylink&utm_campaign= petition_dashboard I would suggest you read the comments left on the petition to see the anecdotal reports of harm for yourself.
I am concerned that increased numbers of patients will be harmed and left with no mechanism by which to report problems.
I would be grateful for your support in this matter.
No response has yet been received.
UPDATE 25 NOVEMBER 2021
Since I published this blog I have also contacted the Care Quality Commission about this issue (no reply received yet) and the petition has reached 1836 signatures. The second phase of the campaign will be launching within the next couple of days. So keep ’em peeled.
There you go, that’s (part of) what I have been working on quietly away from social media since August 2021. Tackling this huge issue for our community one email at a time. There will be many more sent before this issue is resolved, of that I am 100% sure.
and Foggy …. OBVIOUSLY.